The FDA recently approved a new drug for treating schizophrenia and bipolar disorder. The drug is called Vraylar under the brand name and Cariprazine is the generic name for the newly approved medication. Research on the latest FDA approved drug treatment for these mental health conditions showed that almost 2,800 patients with one of these two disorders showed symptom reduction after taking the medication. Forest Laboratories manufactures the drug, and the company detailed receiving the FDA approval for the new drug. The FDA gave approval based on 3 different controlled trials for each disorder, each lasting 3 weeks each for bipolar and 6 weeks each for schizophrenia. The trial participants had either mixed or manic bipolar episodes for the 3 week trials, and symptoms of schizophrenia for the 6 week trial.
After the FDA gave approval for the new drug to treat bipolar disorder and schizophrenia the agency and Forest Laboratories both released statements about the approval. FDA Division of Psychiatry Products Director Mitchell Mathis, M.D. pointed out that “schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities. It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient’s individual needs.”
David Nicholson is the Executive Vice President and President of Global R&D brands of Allergan, the parent company for Forest Laboratories. Nicholson released a statement which read “We are pleased with the FDA approval of Vraylar, which represents an important new treatment option for adults living with bipolar I disorder and schizophrenia to help address the unmet medical needs of people with these complex conditions.”